Recruiting

Observational Study

Sponsor:

Ball State University

Code:

NCT06444984

Conditions

Hyperglycemia, Postprandial

Hyperinsulinemia

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Fasting Trial

Fed Trial

Study Details

Brief summary:

Increasing attention has been paid to meals with unusual characteristics that are consumed on a semi-regular basis (e.g., "tailgating," pizza buffets). The purpose of this study is to describe the acute cardiometabolic effects of a cinema-style meal rich in refined sugar, total carbohydrate, and moderate in fat (i.e., soda, popcorn, candy).

Conditions

Hyperglycemia, Postprandial

Hyperinsulinemia

Study ID

NCT06444984

Start date

Mar 24, 2024

Status verified date

May, 2024

Completion date

Mar, 2025

Anticipated

Primary completion date

Sep, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18-45 years old
  • Not pregnant or expecting to become pregnant (females only)
  • Not postmenopausal (females only).
  • Not been diagnosed with a cardiometabolic conditions (e.g., heart disease, type 2 diabetes)
  • Not been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
  • Does not regularly take anti-inflammatory drugs (more than 2x week) or able to temporarily suspend use of anti-inflammatory drugs.
  • Does not use glucose-lowering drugs (e.g., metformin)
  • Does not use lipid-lowering drugs (e.g., statins)
  • Does not use tobacco products or any illicit drugs.
  • Does not have a pacemaker.

Exclusion Criteria:

  • Not 18-45 years old
  • Pregnant or expecting to become pregnant (females only)
  • Postmenopausal (females only).
  • Been diagnosed with a cardiometabolic conditions (e.g., heart disease, type 2 diabetes)
  • Been diagnosed with a chronic inflammatory condition (e.g., rheumatoid arthritis, inflammatory bowel disease).
  • Regularly take anti-inflammatory drugs (more than 2x week) or unable to temporarily suspend use of anti-inflammatory drugs.
  • Use glucose-lowering drugs (e.g., metformin)
  • Use lipid-lowering drugs (e.g., statins)
  • Use tobacco products or any illicit drugs.
  • Has a pacemaker.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Fasting Meal Trial

During the fasting meal trial, participants will report fasted and consume a movie theater style meal.

experimental: Fed Meal Trial

During the fed meal trial, participants will report fasted and first consume a high-fat breakfast. Participants will then be asked to consume a movie theater style meal three hours later.

Interventions

Fasting Trial

Participants will report fasted and consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles) in the morning.

Fed Trial

Participants will report fasted and first consume a high-fat meal (Jimmy Deans) in the morning. After a three-hour break, participants will consume popcorn (6 cups popped microwave popcorn), soda (32 oz Coke-a-cola), and candy (2.17 oz of Skittles).

Primary outcome measure

  • Glucose [ Time Frame: Through study completion, up to 1 year. ]
  • Insulin [ Time Frame: Through study completion, up to 1 year. ]
  • Triglycerides [ Time Frame: Through study completion, up to 1 year. ]
  • HDL-C [ Time Frame: Through study completion, up to 1 year. ]
  • Lipopolysaccharide binding protein (LBP) [ Time Frame: Through study completion, up to 1 year. ]
  • soluble CD14 (sCD14) [ Time Frame: Through study completion, up to 1 year. ]
  • Interleukin (IL)-6 [ Time Frame: Through study completion, up to 1 year. ]
  • Flow-mediated dilation [ Time Frame: Through study completion, up to 1 year. ]

Central Contacts and Locations

Central contacts

Bryant Keirns, PhD

7652858356bryant.keirns@bsu.edu

Locations

Health Professions Building, Ball State University

Recruiting

Muncie, Indiana, United States, 47306

Contacts

Bryant Keirns, PhD

765-285-8356bryant.keirns@bsu.edu

More Information

Sponsor

Ball State University

Last update posted

Jun 6, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ball State University on 2024-06-06.